In fact, the United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for UDI. And, in addition, manufacturers also need to comply with the EU Regulations on medical devices (MDR) and in vitro diagnostic devices (IVDR), as well as 21 CFR Part 11.
Although these standards are essential to patient safety and enable an efficient process for all healthcare stakeholders worldwide, it can also be a regulatory challenge to those manufacturers who need to maintain compliance for each label on every product, which often needs to be done in multiple languages.
Understanding the challenges
Therefore, it's not surprising that almost one third of senior medical supply chain executives list regulatory compliance as the biggest challenge facing their industry. And, as much of the regulation concerns identifying products correctly, labelling has taken centre stage.
The pressure to reduce costs, especially in the supply chain, is another challenge facing device manufacturers, as is maintaining quality and reducing labelling errors. In a worst-case scenario, labelling errors could potentially lead to lawsuits … but even minor errors result in product recalls, which can be extremely costly in terms of both time, labour and potentially lost business.
Ken Moir
One company that was facing such challenges is LiNA Medical. Its extant labelling process required the production identifier portion of the UDI and other information to be manually entered, leading to frequent misspelling and other errors. In addition, it was possible for production operators to change labels by accident and the print history needed to be manually tracked for compliance. Clearly, there was a need in terms of regulatory compliance, quality improvements and cost implications, to move to a more seamless and transparent process.
Solving the problems
A modern label management system (LMS) provides the traceability required by FDA UDI and EU MDR/IVDR regulations. It guarantees that all labels include the required UDI device identifier and production identifier information, as well as clearly logging actions and the print history to respond to regulatory audits. Also, only one version of the “true” label is held, minimising the likelihood of errors.
When business rules are established in the LMS, users can handle label changes without causing permanent changes to the approved template, leading to a more efficient process and one with fewer errors as well. Consequently, the whole process is less costly.
Quality control can also be ensured with a modern LMS — as information can only be accessed by authorised personnel; plus, it provides a complete and auditable label change and print history for anyone with access.
LiNA Medical realised these benefits through the implementation of a modern LMS system. All its work orders are now integrated within its labelling processes. There is a centralised document management system for UDI-compliant labelling and all label designs and approval workflows are streamlined and happen within the system. The whole process is also completely transparent as all label variants are completely traceable.
This has led to a more agile environment in which label changes happen in a fraction of the time that they used to, and mislabelling incidences have dropped, resulting in time and cost savings for LiNA Medical.
Conclusion
Quality and compliance are essential in the medical devices industry, but this can come at a cost. However, implementing an LMS can minimise inaccuracies and improve quality control processes, therefore avoiding costly errors and maintaining compliance.
Companies relying on a legacy systems approach to labelling often need a lot of manual processes and they could struggle to compete with other more agile device manufacturers. With such clear benefits, it makes sense to implement a modern LMS now, before industry regulations tighten any further and processes become even more unwieldy.